This invention relates to biosensing meters and test strips, and more particularly, to subscription based biosensor monitoring systems.
Common biosensor monitoring systems for measuring a significant characteristic of bodily fluid, such as coagulation time or glucose levels, include disposable test strips for use in a biosensing meter. Particular use of such test strips has been made for measuring glucose in human blood. Such test strips have been used by diabetics and health care professionals for monitoring their blood glucose levels. The test strips are usually used in conjunction with the biosensing meter. The meter may measure light reflectance, such as specular reflection, if the strip is designed for photometric detection of a dye, or the meter may measure an electrical property, such as electrical current, if the strip is designed for detection of an electroactive compound.
In meters for calculating and displaying the results of reactions of medically significant characteristics (e.g., glucose, coagulation time) of biological sera (e.g., blood, urine or the like) on test strips, it is well known that the test strips are not precisely reproducible from batch to batch. Accordingly, calibration data must be realized for each batch of test strips and provided to the biosensing meter to obtain accurate test results. The calibration data is often provided via an electronically readable information carrier, such as a read only memory (ROM) circuit, which is plugged into a socket in the biosensing meter. The socket electronically couples the ROM circuit to a microprocessor/controller in the biosensing meter. Because the calibration data is germane to the test strip batch, the ROM circuit is provided with a vial of test strips (e.g., a quantity of 50 tests strips from the same batch) so that accurate test results may be obtained for the entire vial. Thus, upon receiving a new vial of test strips, the user inserts the new ROM circuit into the biosensing meter, and uses this same ROM circuit for the entire vial of test strips.
Biosensing meters often include a memory device to store a number of recent test results. These stored test results are used to provide trend data to the user, which is then available to a health care provider to foster better therapy decisions. The accuracy of the historical data and trend data in tracking the user""s condition is dependent on the testing frequency. Thus, users may desire to conduct biosensing tests frequently.
However, the frequency of testing is directly proportional to the user""s cost, as test strips are sold on a quantity basis. Thus, users often limit their testing frequency to keep their individual monitoring costs down, even though this compromises the accuracy of the historical data, trend data tracking, and predicting the users"" conditions. Additionally, if the user has a contract with a reimbursement institution, such as a health insurance carrier, the reimbursement institution may also limit the number of test strips used per day. Also, many users have become visually impaired, and/or their manual dexterity has deteriorated as a result of their medical condition, resulting in test strips being damaged before or during insertion into the biosensing meter, thereby artificially inflating monitoring costs for these users.
A subscription based biosensor monitoring system provides a user with a higher testing frequency at a fixed cost. The subscription based monitoring system involves providing vials of test strips in a reasonable, but essentially unlimited, quantity to the user for a fixed subscription period cost (e.g., monthly, bimonthly, etc.). Thus, a user under a subscription agreement may more accurately track a medically significant characteristic of biological fluid (e.g., glucose, coagulation time), and thereby more accurately monitor his or her condition, at a fixed cost.
Unfortunately, existing biosensing meter technology cannot distinguish between subscription and non-subscription test media. Furthermore, existing biosensing meter technology cannot ensure that a subscription user is not giving a vial provided under subscription to a non-subscription user. As each vial is provided with a ROM circuit containing calibration data, and the ROM circuit may be used in any corresponding meter, a user could provide the entire vial and ROM circuit to a non-subscription user, or temporarily loan the vial and ROM circuit to a non-subscription user. This fraudulent activity reduces cost for the users, but drastically increases the cost for the suppliers and manufacturers of test strips sold on a subscription agreement.
Thus, there is a need for a subscription based biosensor monitoring system, and also a need for a subscription based biosensing monitoring system that is fraud resistant.
The invention provides a subscription based biosensor monitoring system and method. The invention guards against fraudulent activity by ensuring that the vial of test strips and a ROM circuit may only be used with an identified biosensing meter.
If the vial and ROM circuit are provided to a different biosensing meter, the biosensing meter will not activate.
The invention includes a system for monitoring a medically significant characteristic of a bodily fluid, the system including a biosensing meter identified as a subscription meter by a first identifier and having a controller being adapted to activate the meter upon receiving an activation code, and a test media identified as subscription test media by a second identifier, the test media associated with the biosensing meter.
The invention also includes a registry associating the first identifier to the second identifier, and providing an activation code to the controller.
Additionally included in the invention are unique first and second identifiers, the unique identifiers providing enhanced security against fraudulent activity.
The invention also includes a method for subscription monitoring of a medically significant characteristic of a bodily fluid, the method including the steps of identifying a biosensing meter as a subscription meter, identifying a test media as subscription test media, associating the identified biosensing meter to the identified test media, and activating the identified biosensing meter by the association. The step of activating the identified biosensing meter includes the steps exchanging information between the biosensing meter and a registry, and retrieving an activation code from the registry.
The method of the invention also includes uniquely identifying the biosensing meter and uniquely identifying the test media, and associating the uniquely identified biosensing meter and uniquely identified test media to a subscription user.
Another method of the invention includes uniquely identifying a biosensing meter, associating the uniquely identified biosensing meter to a particular user, uniquely identifying a set of test media, and associating the uniquely identified biosensing meter to the uniquely identified set of test media. Then, it is determined whether the particular user is an authorized subscriber, and when the particular user is an authorized subscriber, activating the uniquely identified biosensing meter for use with the uniquely identified set of test media, and monitoring the use of the uniquely identified set of test media with the uniquely identified biosensing meter by the particular user.
Additionally, a method for monitoring a medically significant characteristic of a bodily fluid includes the steps of identifying a biosensing meter as a subscription meter, establishing a subscription period, and providing a test media during the subscription period.